BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    THERMAFLEX, MODEL SD 55 C.P.M.H.

    K Number: K945803 · Decision May 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    7
    Review Days
    164

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    THERMAFLEX, MODEL SD 55 C.P.M.H.
    K Number
    K945803
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5410
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Burke Neutech, Inc.
    Date Received
    November 28, 1994
    Decision Date
    May 11, 1995
    Product Code
    JFA
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JFA Exerciser, Finger, Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JFA), ordered by most recent decision date.

    JACE MODEL H440 HAND CPM DEVICE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HAND THERAPY ASSOST

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    JACE MODEL PM-410 HAND CPM DEVICE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MOBILIMB H3 HAND CPM UNIT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DANNIFLEX CPM 880(TM)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TORONTO/MOBILIMB HAND C.P.M.

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Burke Neutech, Inc.

    K Number Device Name
    K955326 SPORTS CONTRAST THERAPY SYSTEM ST 7000
    K952117 EPILATOR
    K943497 CONTRAST 7000 THERAPY SYSTEM
    K942926 NEURO-AIDE
    K940160 TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
    K926151 LSI6000 THERMAL THERAPY SYSTEM